Common use of Control and Ownership of Regulatory Filings Clause in Contracts

Control and Ownership of Regulatory Filings. (a) Subject to Section 11.4, [***] shall have sole discretion, control and responsibility to draft, prepare, submit and file, [***] all INDs, BLAs, the CMC filing, and other regulatory documents, dossiers and filings, (collectively, “Regulatory Filings”) in the Territory with respect to any Development Candidates or Licensed Products in the Field; provided that [***]. All such Regulatory Filings shall be in the name of, and be owned solely by, [***], other than [***], which shall be in the name of, and be owned solely by, [***]. In addition, [***] shall have sole control and responsibility in the conduct of all pricing and reimbursement approval proceedings related to the Licensed Products. (b) [***] will consult with [***] with respect to those portions of Regulatory Filings which include [***], by providing [***] with the relevant portions of those proposed filings to allow [***] a reasonable opportunity for review and comment before such filings are due. [***] will accept changes to [***] of any Regulatory Filings proposed by [***] if they are commercially reasonable for [***]. To extent that any Regulatory Filings concern [***] and apply [***] or [***] licensed hereunder, then [***] shall be entitled to include such information in the [***].